Kornimate/medical-research-clean huggingface dataset:
a phase ib/ii study of aeb071 and mek162 in adult patients with metastatic uveal melanoma

Conditions: Uveal Melanoma

Summary: a phase ib dose-escalation study of the aeb071 and mek162 combination in adult patients with confirmed metastatic uveal melanoma. cohorts of 3-6 patients will be assessed for dose limiting toxicities (dlts) during cycle 1 until the maximum tolerated dose (mtd) of the combination therapy is determined. the mtd or phase 2 recommended dose (p2rd) will be used in a phase ii part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or mek162 alone. the phase ii part will continue until proof of concept is established. patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

due to halted enrollment, the phase ii part of the study was not conducted. the sponsor decided to permanently stop recruitment for the study prior to mtd determination. remaining patients on treatment with binimetinib and sotrastaurin who were considered by the investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. no patients were ongoing as of the data cut-off date. after the last patient last visit (lplv) was declared, the study was terminated.

Eligibility criteria:
inclusion criteria: * written informed consent * male and female patients aged 18 years or older * a history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease * consent to providing 3 tumor biopsy samples throughout the course of the study * presence of measurable disease * a who performance status of less than or equal to 1 exclusion criteria: * presence of cns lesions (stable lesions may be acceptable) * previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years * adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to ctcae v4.03 grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than grade 2 * history or current evidence of retinal vein occlusion (rvo) or current risk factors for rvo * impaired cardiac function or clinically significant cardiac disease * impaired gi function or disease that could interfere with the absorption of aeb071 and/or mek162 * treatment with medicines or herbal supplements that are known inhibitors or inducers of cyp3a4/5 and cannot be withdrawn prior to study treatment * females of child-bearing potential who are unwilling or unable to use highly effective means of contraception * males who are unwilling or unable to use a condom during sexual intercourse * prior exposure to a mek or pkc inhibitor other inclusion/exclusion criteria apply

Keywords: melanoma, melanoma of the eye, uveal, mek162, aeb071
diflucan research for infant evaluation of antifungal treatment and prophylaxis medication

Conditions: Deep Mycosis

Summary: to collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.


Eligibility criteria:
inclusion criteria: * male or female under age of seven patients who are prescribed fluconazole (diflucan) for antifungal treatment or prophylaxis administration. exclusion criteria: * subject of seven years or more who have been prescribed fluconazole.

Keywords: antifungal treatment prophylaxis administration japanese infants fluconazole diflucan regulatory post marketing commitment plan.
a study to assess the safety, tolerability and efficacy of rg2417 in bipolar i depression

Conditions: Bipolar I Depression

Summary: the purpose of this study is to test a new drug, rg2417, to see how the drug affects symptoms of bipolar i depression and to make sure it is safe in humans.


Eligibility criteria:
inclusion criteria: * bipolar i disorder, most recent episode depressed * history of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms exclusion criteria: * current manic, hypomanic or mixed episode * rapid cycling bipolar disorder (4 or more mood episodes in the last year) * dementia or any other axis i diagnosis (besides bipolar i) that requires treatment * alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months * positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(pcp) * axis ii diagnosis likely to interfere with study compliance * serious suicidal or homicidal risk * sensitivity to any of the drug ingredients, including lactose * women who are pregnant, breast feeding or refuse to use adequate birth control * current seizure disorder * current episode of depression is longer than 1 year

Keywords: bipolar depression bipolar disease bipolar disorder bipolar manic depression manic depressive disorder
validation of the french version of the fremantle back awareness questionnaire (frebaq) in patients with chronic low back pain

Conditions: Low Back Pain

Summary: in patients with chronic low back pain, the fremantle back awareness questionnaire (frebaq) measures the duration and intensity of pain and functional limitations. the frebaq is a simple tool created to assess disturbances in the body representation of the back, and the only one existing in chronic low back pain. it is a 9-item self-questionnaire in which each item is measured on a 5-point likert scale ranging from "never (score of 0)" to "always (score of 4)". it assesses neglect, perceived body image of the back, accuracy in proprioceptive perception of back movements. the psychometric properties of the frebaq in english, japanese, dutch, turkish and german are validated and acceptable; however, they have never been studied in french and no validated version of this questionnaire in french exists. the study investigators hypothesize that the french version of the frebaq has good psychometric qualities, allowing it to be used in the french chronic low back pain population.


Eligibility criteria:
inclusion criteria: * subject with no history of chronic low back pain and with a lumbar vas \<2 for more than 3 months. * patient with chronic low back pain: pain localized between the edge of the last lower ribs and the intergluteal groove (17) for more than 3 months. * patient with a lumbar vas \> 2 for more than 3 months. * patient whose low back pain is of common origin (no underlying organic etiology). * in case of lumbar-radicular pain, patient with a vas (lumbar) \> vas (leg) * patient who speaks and understands french * patient with no history of arthrodesis or lumbar disc prosthesis * subject affiliated or beneficiary of a health insurance plan. * the patient must have given their free and informed consent and signed the consent form exclusion criteria: * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient pregnant, parturient or breastfeeding
education with inhalers in patients with copd exacerbation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a public health problem with great morbidity. the main therapeutic strategy is inhalers. the objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with copd including ventilatory re-education and video recordings of the patients themselves.

the importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. in europe, it is estimated that 50% of adult patients do not use the inhaler correctly. the clinical development of copd includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. during these hospitalizations, respiratory symptoms are worsening.nevertheless, in europe, it is estimated that 50% of adult patients do not use the inhaler correctly. thus, it is very important the pharmacological education in this patients.

Eligibility criteria:
inclusion criteria: * inclusion criteria were to be clinically diagnosed of exacerbation of copd, to possess pharmacological treatment in the form of inhalers. exclusion criteria: * exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. patients who had experienced an exacerbation of prior copd in less than one month were excluded.

Keywords: education dry powder inhalers metered dose inhalers pulmonary disease chronic obstructive
clinical study of self-gripping mesh in tapp versus lichtenstein hernia repair

Conditions: Inguinal Hernia

Summary: the goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. the main question it aims to answer is, in which procedure is the self-gripping mesh more effective. participants will be divided into the tapp group and the lichtenstein group by random number table method, the tapp group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the lichtenstein group underwent lichtenstein hernia repair, both groups used self-gripping meshes. researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus lichtenstein hernia repair.


Eligibility criteria:
inclusion criteria: * male patients aged 18 years and older. * patients with a definite diagnosis of unilateral primary inguinal hernia. * patients and their families were informed about the study protocol and agreed to participate in the study. exclusion criteria: * patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias. * patients with previous history of lower abdominal surgery. * patients with contraindications to anaesthesia. * patients with contraindications to laparoscopic surgery. * failure to follow up patients as scheduled. * patients with abdominal infections. * those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.

Keywords: self-gripping mesh laparoscopy herniorrhaphy
randomized study of open mesh repair in local anesthesia versus cost-optimized laparoscopic repair for inguinal hernia

Conditions: Hernia, Inguinal

Summary: the purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (tep) for primary inguinal hernia. the investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. the study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.


Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia * suitable for open mesh repair in local anesthesia as well as laparoscopic repair * asa score i-iii * informed consent exclusion criteria: * asa score iv (not suitable for tep) * bilateral hernias (laparoscopic repair preferable) * recurrent hernia (primary repair affects preferable treatment) * large scrotal hernias (not suitable for local anesthesia) * earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for tep)
effect of lacidipine and losartan on 24 hour systolic blood pressure variability in elderly hypertensive patients

Conditions: Hypertension

Summary: the aim of this study is to evaluate the effect of lacidipine and losartan in elderly hypertensive patients on reducing the 24 hour systolic bp variability, which is one of the potential parameter to consider in treating elderly hypertensive patients.

in this study, we investigate the effects of two anti-hypertensive medications on systolic bp variability profile as a pilot study. this is a prospective, randomized, open-label, blinded end point (probe), parallel group study with two treatment arms. at the end of an initial 2-week washout period, during which any eventual anti-hypertensive drug is discontinued, patients fulfilling the inclusion criteria are randomly treated with the lacidipine (4 mg) or losartan (50 mg), both given once daily at the same hour in the morning (approximately at 8 am) for 12 weeks. if the bp goal (sbp \< 140 mmhg and dbp \< 90 mmhg) has not been attained after 4 week's treatment, 12.5 mg hydrochlorothiazide (hcts) once daily can be added. patients are checked 24-h ambulatory bp monitoring (abpm) at the end of the washout period and after 12 weeks of active treatment. at each visit, seated cuff sbp and dbp, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded.

Eligibility criteria:
inclusion criteria: * elderly patients (age \> 65 years) * essential hypertension (systolic bp \> 140 mmhg or diastolic bp \> 90 mm hg) * provide written informed content exclusion criteria: * secondary hypertension * myocardial infarction or cerebrovascular accident within the preceding 6 months * clinically significant valvular heart disease, heart failure (class iii, iv), renal insufficiency (serum creatinine \> 2.5mg/dl), hepatic failure, uncontrolled diabetes mellitus * known hypersensitivity to the drugs used in the study.

Keywords: systolic hypertension
research study comparing a new medicine semaglutide to liraglutide in people with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. the study will last approximately 9 months (37 weeks). each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. at the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. participants will also fill in some forms about their health and satisfaction with their diabetes treatment.


Eligibility criteria:
inclusion criteria: - male or female, age 18 years or older at the time of signing informed consent - diagnosed with type 2 diabetes mellitus - hba1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) sglt-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) exclusion criteria: - family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. family is defined as a first degree relative - history or presence of pancreatitis (acute or chronic) - history of diabetic ketoacidosis - any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - subjects presently classified as being in new york heart association (nyha) class iv - planned coronary, carotid or peripheral artery revascularisation known on the day of screening - renal impairment measured as estimated glomerular filtration rate (egfr) value of below 30 ml/min/1.73 sqm as defined by kdigo 2012 classification - impaired liver function, defined as alt above or equal to 2.5 times upper normal limit at screening - proliferative retinopathy or maculopathy requiring acute treatment. verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
a first-in-human, phase 1 study of jab-3312 in adult patients with advanced solid tumors

Conditions: Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Ductal Carcinoma; Esophageal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Breast Cancer; Other Solid Tumors

Summary: this is a phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) and assess the dlt of jab-3312. it is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. jab-3312 will be administered orally once daily (qd) in 21-day treatment cycles.


Eligibility criteria:
inclusion criteria: 1. subject must be ≥18 years-of-age at the time of signature of the informed consent form (icf). 2. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 3. subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. 4. subjects with life expectancy ≥3 months. 5. patients must have at least one measurable lesion as defined by recist v1.1. 6. patients who have sufficient baseline organ function. exclusion criteria: 1. severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent). 2. known malignant central nervous system disease other than neurologically stable, treated brain metastases. 3. history or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. 4. 8. history of seropositive status for hepatitis b, hepatitis c and human immunodeficiency virus (hiv). 5. history or evidence of active infections (grade ≥2). 6. history or evidence of significant inflammatory or vascular eye disorder. 7. history of an allogeneic bone marrow or solid organ transplant. 8. use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of jab-3312. 9. history of radiation therapy ≤28 days prior to the first dose of jab-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of jab-3312. 10. history of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. 11. subjects experiencing unresolved grade \>1 toxicity before the start of treatment.

Keywords: src homology phosphatase 2 (shp2) ptpn11 kirsten rat sarcoma (kras) proto-oncogene, gtpase epidermal growth factor receptor (egfr)
schnitzler syndrome: clinical study, physiopathological and search for genetic factors

Conditions: Schnitzler Syndrome

Summary: the schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent fever in a patient with a monoclonal igm component. other frequent signs include joint, bone and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate (bsr), elevated neutrophil count and abnormalities on bone morphologic investigations. in 2001, the investigators proposed criteria to diagnose this syndrome, which are currently admitted in the literature. the main complications of the schnitzler syndrome are a difficult-to-control inflammatory anemia, aa-amyloidosis and malignant b lymphoproliferative disorders. about 15% of patients with a schnitzler will eventually develop a lymphoproliferative disorder; thus this syndrome allows studying the relationship between lymphomagenesis and inflammation. by many aspects, the schnitzler syndrome is reminiscent of auto-inflammatory syndromes. though the term auto-inflammatory disease is as to yet restricted to diseases with mendelian inheritance, some polygenic inflammatory diseases like for example crohn's disease clearly involve pathogenetic pathways shared with the monogenic auto-inflammatory syndromes. the investigators stipulate that this could also be the case in the schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate very similar to the one observed in the auto-inflammatory cryopyrinopathies (cinca/nomid syndrome, muckle-wells syndrome and familial cold-urticaria); the investigators recently individualized this particular eruption, significantly associated with systemic inflammatory disease, within the group of neutrophilic urticarias (kieffer et al. medicine, in press); (3) the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients with majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of neutrophil count, not otherwise explained; (5) a spectacular response to the il-1 inhibitor, within hours after the first injection, similar to what is reported in the papa (pyogenic arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a direct pathogenic effect of il-1.


Eligibility criteria:
inclusion criteria: * patients with the schnitzler syndrome according to criteria established by lipsker d et al. medicine (baltimore) 2001;80:37-44 exclusion criteria: * children and pregnancy

Keywords: schnitzler syndrome waldentsröm's disease anakinra